FDA Litigation

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges.

  • Achieved victory for NDA holder in face of a challenge to the agency’s approval of its cutting-edge 505(b)(2) application for ARISTADA®.
  • Goodwin successfully defended Alkermes’ FDA approval of the schizophrenia drug ARISTADA in the face of an Administrative Procedure Act challenge by another drug manufacturer. The case involved issues of first impression under the Federal Food, Drug, and Cosmetics Act (FDCA), concerning exclusivity the FDA grants to manufacturers that conduct studies on new ways to use an already approved drug. Goodwin helped Alkermes win a resounding victory in July 2016, when the federal district court rejected all the challenger’s claims seeking to vacate Alkermes’ approval. The decision is likely to be an important and precedent-setting one for life sciences companies seeking approval of drugs under the Section 505(b)(2) pathway.

  • Protected ANDA holder’s interest in retaining regulatory approval for the first generic launch of Nexium®.
  • Goodwin successfully defended Teva in a challenge to the FDA’s decision to approve the first generic version of Nexium. Another generic drug manufacturer contended that it was entitled to 180-day first-generic-entrant marketing exclusivity. The district court denied the challenger’s claims, resolving several issues of first impression concerning 180-day exclusivity.  Goodwin led the efforts on appeal among multiple generic intervenors, and the generic drug challenger dismissed its appeal on the eve of oral argument.

  • Defended ANDA holders’ approvals to launch the first-ever generic versions of the blockbuster drug Abilify®.
  • Goodwin led the defense of several generic drug manufacturers in the fact of a challenge to the FDA’s decision to approve generic versions of the blockbuster drug, Abilify. The manufacturer of Abilify contended that an interplay between orphan drug exclusivity and pediatric uses precluded generic drug approvals. Deciding an issue of first impression, the district court denied the challenges and upheld the generic drug companies’ right to market generic versions of Abilify. The challenger declined to appeal.

Publications

Alert
FDA Draft Guidance on Updating Generic Labels When RLD Withdrawn
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